VALVE, IMPLANT INCLUDING THE VALVE, FLUID TRANSFER ARRANGEMENT, AND METHOD OF TREATMENT USING THE SAME

• US 20140276345A1
• Filed: 03/12/2014
• Published: 09/18/2014
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Douglas D. Silin
• Original Assignee: Douglas D. Silin
• Inventors: Silin, Douglas D.
• Granted Patent: US 10,086,129 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/223 Multiway valves

Abstract

A valve includes a housing with a cavity having at least one connector fluidically connecting the cavity to an outside of the housing and a plug that is movable within the housing. The plug is movable at least between a first position that substantially occludes fluidic communication between the cavity and an outside of the housing through the at least one connector and a second position that allows fluidic communication between the cavity and the outside of the housing through the at least one connector. The valve also includes a septum in operable communication with the housing that is sealingly penetrable by a fluid transfer device, wherein the fluid transfer device is capable of moving the plug between at least the first position and the second position.

Claims

1. A valve comprising:

a housing defining a cavity having at least one connector fluidically connecting the cavity to an outside of the housing;

a plug being movable within the housing at least between a first position that substantially occludes fluidic communication between the cavity and an outside of the housing through the at least one connector, and a second position that allows fluidic communication between the cavity and the outside of the housing through the at least one connector; and

a septum in operable communication with the housing and being sealingly penetrable by a fluid transfer device, wherein the fluid transfer device is capable of moving the plug between at least the first position and the second position.

2. The valve of claim 1, wherein the at least one connector is fluidically connectable to a blood vessel, a biocompatible tube, or a combination thereof.

3. The valve of claim 1, wherein the at least one connector is a first connector and a second connector.

4. The valve of claim 3, wherein and the plug occludes fluidic communication between the first and second connectors when in the first position and allows fluidic communication between the first and second connectors when in the second position.

5. The valve of claim 1, wherein the fluid transfer device is a syringe, a hollow bore needle, a cannula, or a catheter.

6. The valve of claim 1, further comprising a rotor having a keyway receptive to the fluid transfer device.

7. The valve of claim 6, wherein a cross sectional shape of the keyway is noncircular.

8. The valve of claim 6, wherein a coupling connects the rotor to the plug.

9. The valve of claim 8, wherein the coupling is configured to bias the plug against a seat located proximate to the at least one connector.

10. The valve of claim 1, wherein the septum includes an opening receptive to the fluid transfer device.

11. The valve of claim 10, wherein the opening is circular.

12. The valve of claim 10, wherein the opening in the septum is able to reseal itself to fluidic communication between the cavity and an outside of the housing through the opening after removal of the fluid transfer device.

13. The valve of claim 1, wherein the septum includes a position indicator, which correlates to a position of the plug.

14. The valve of claim 1, further comprising a seat arranged proximate to the at least one connector.

15. The valve of claim 14, wherein the seat is sealingly receptive to the plug.

16. The valve of claim 15, wherein the plug fills a volume of at least an outer portion of the connector.

17. The valve of claim 1, wherein the valve is implantable within a patient'"'"'s body.

18. The valve of claim 1, wherein the plug is sized and configured to substantially fill a volume defined by the at least one connector when the plug is in the second position.

19. A fluid transfer arrangement, comprising:

a valve being implantable under skin and having a first connector and a second connector, wherein the first and second connectors are fluidically connectable to first and second blood vessels, wherein fluidic communication between the first and second blood vessels is occluded when a plug within the valve is in a first position and allowed when the plug is in a second position, wherein the plug is movable between at least the first position and the second position by a fluid transfer device, which is engagable with the valve and able to move the plug between at least the first position and the second position.

20. The fluid transfer arrangement of claim 19, wherein the valve is sealable to the fluid transfer device while the fluid transfer device is engaged with the valve.

21. The fluid transfer arrangement of claim 19, wherein fluid is transferable through the fluid transfer device while the fluid transfer device is engaged with the valve.

22. The fluid transfer arrangement of claim 19, wherein the valve seals an opening receptive to the fluid transfer device upon removal of the fluid transfer device.

23. The fluid transfer arrangement of claim 19, wherein movement of the plug between the first position and the second position is in response to rotation of the fluid transfer device.

24. The fluid transfer arrangement of claim 19, wherein the valve is configured to be engaged and disengaged repeatedly by the fluid transfer device.

25. The fluid transfer arrangement of claim 19, wherein the first blood vessel is an artery and the second blood vessel is a vein.

26. An implant, comprising:

a valve which is implantable within a human body and which comprises at least one connector,

wherein the at least one connector is in operable communication with the valve, which is openable and closable to flow in response to rotation of a fluid transfer device while the fluid transfer device is engaged with the valve.

27. The implant of claim 26, wherein the valve further comprises a septum that seals fluid within the valve regardless of whether or not the fluid transfer device is engaged with the valve.

28. A method of dialysis, the method comprising:

locating a valve disposed within a patient;

inserting a fluid transfer device in a keyway of the valve;

rotating the fluid transfer device with respect to a housing of the valve to open the valve; and

communicating a fluid through the fluid transfer device to perform dialysis, wherein the valve comprises

a housing defining a cavity having at least one connector fluidically connecting the cavity to an outside of the housing,

a plug being movable within the housing at least between a first position that substantially occludes fluidic communication between the cavity and an outside of the housing through the at least one connector and a second position that allows fluidic communication between the cavity and the outside of the housing through the at least one connector, and

a septum in operable communication with the housing and being sealingly penetrable by a fluid transfer device, the fluid transfer device being capable of moving the plug between at least the first position and the second position.

29. The method of claim 28, further comprising administering a postdialysis composition through the fluid transfer device to remove a residual fluid from the valve.

30. The method of claim 29, wherein the postdialysis composition is heparinized saline.

31. The method of claim 30, wherein the residual fluid is blood, and wherein the administering replaces the blood with the heparinized saline.

32. The method of claim 29, wherein the valve comprises a first valve connected to a vein and a second valve connected to an artery, wherein the first valve and the second valve are connected by a tube, and

wherein the method further comprises administering a postdialysis composition to the first valve, the second valve, and the tube to remove the residual fluid from the first valve, the second valve, and the tube.

33. The method of claim 32, wherein the administering of the postdialysis composition comprises replacing the residual fluid with the postdialysis composition.

34. The method of claim 32, wherein the tube is a biocompatible tube.

35. The method of claim 28, further comprising rotating the fluid transfer device with respect to the housing of the valve to close the valve, wherein the rotating urges a plug of the valve to engage the at least one connector of the valve such that a volume of at least an outer portion of the connector is filled by the plug.